Shoulder PainNCT02419040
Treatment of Calcific Tendinitis of the Rotator Cuff
A study testing Barbotage and Corticosteroid injection in people with Shoulder Pain and Tendonitis, run by Vestre Viken Hospital Trust at 1 site in Norway.
Trial summary
The purpose of this study is to determine whether the combination of removal of the calcification in calcific tendinitis of the shoulder (supraspinatus and/or infraspinatus tendon) by aspiration with a needle and syringe (barbotage) and a corticosteroid injection is more effective than corticosteroid or sham injection… Read more about this study
- Who is it for?
- Ages 30 to 100 years
- Conditions the study is for
- Shoulder Pain, Tendonitis, Calcinosis
- What is being tested?
- Barbotage and Corticosteroid injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2015to Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 30 years or older
- 3 months or more of shoulder pain
- Moderate to strong pain localized on the top and/or lateral side of the shoulder, exaggerated by activities above shoulder level
- Painful arc
- Positive Hawkin's test and/or Neer's sign for impingement
- Finding of one or more calcifications ≥5 mm in size on a standard anteriorposterior radiograph, localized proximally to the greater tubercle, together with a sonographic finding of one or more calcifications ≥5 mm in size on the short or long axis view, localized in the supraspinatus or infraspinatus tendon
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- Morphological radiographic appearance of Molé type A, B or C12 (appendix 2) A: Dense, homogeneous with well-defined limits B: Dense, fragmented with well-defined limits C: Heterogeneous with poorly defined limits and sometimes with a punctuate appearance
- Ability to understand written and spoken Norwegian (Swedish/English)
- Existing signed informed consent and expected cooperation of the patients for the treatment and the follow-up
Who cannot join
- Clinical and radiological signs of a recent spontaneous release of the deposit such as a sudden change in size or density of the deposit on ultrasound together with an acute onset of extreme shoulder pain
- Clinical signs of shoulder instability, glenohumeral arthritis, AC pathology, inflammatory arthropathy, fibromyalgia, frozen shoulder or cervical radiculopathy
- Sonographic signs for a rotator cuff tear (full thickness or partial thickness) and of a tear or a dislocation of the long head of the biceps tendon
- A history of surgical treatment of the relevant shoulder
- A subacromial injection with a corticosteroid during the last 3 months before inclusion
- Medical contraindications for any of the invasive procedures
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- One of the following contraindications for the use of Lidocaine 10 mg/ml: Patients with serious hypovolaemia, known cardiac conduction disturbances, epilepsy or porphyrias, patients with known serious dysfunction of the liver or the kidneys.
- One of the following contraindications for the use of Triamcinolone 20 mg/ml: Patients with systemic infections unless specific anti-infective therapy is employed, patients with a local infection in the area of application, patients recently vaccinated with live vaccines, patients with known diabetes mellitus, renal or cardiac insufficiency, ulcerating colitis, gastric ulcer, psychosis, idiopathic thrombocytopenic purpura, or ocular herpes simplex.
- Concomitant medication with one of the following medicinal products: Anti-arrythmics such as mexiletine or class III antiarrythmics (e.g. amiodarone), muscle relaxants (e.g. suxamethonium) or antipsychotics (e.g. pimozide, sertindole, olanzapine, quetiapine, zotepine, tropisetrone, dolasetron), antibiotics such as quinopristin/dalfopristin.
- Any history of prior allergic/hypersensitivity reactions related to the study medication
- Knowledge of an ongoing pregnancy (Fertile women not using contraception and who are uncertain whether they are pregnant or not will have to perform a pregnancy test)
- Nursing women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Calcific Tendinitis of the Rotator Cuff - a Multi-centre, Randomized and Sham Controlled Trial (KALK Study)
The purpose of this study is to determine whether the combination of removal of the calcification in calcific tendinitis of the shoulder (supraspinatus and/or infraspinatus tendon) by aspiration with a needle and syringe (barbotage) and a corticosteroid injection is more effective than corticosteroid or sham injection alone.
Read the detailed description
Barbotage is a sonographically guided percutaneous needle aspiration and lavage of the calcium deposit in calcific tendinitis of the shoulder. Persisting pain in cacific tendinitis is considered to be a consequence of increased tendon volume or changed tendon texture in the area of the calcification which leads to secondary impingement and inflammation. Consequently, removal of the deposit should be a causal treatment measure.
Scientific evidence for the efficacy of the barbotage procedure in patients with persistent symptoms from calcific tendinitis is still limited. The cyclic often self-limiting course of the disease, and an anticipated placebo effect, questions about the method's efficacy can only be answered by high-quality randomized studies. In this trial the investigators want to randomize a cohort of patients to (1) Ultrasound guided needling, lavage and subacromial steroid injection, (2) Ultrasound guided subacromial steroid injection or (3) Ultrasound guided lidocain injection (sham). The investigators want to follow the patients over two years with repeated testing with a set of validated outcome measures together with radiologic re-examinations. The investigators want to find out whether the active treatments (1, 2) are more effective than the sham treatment and whether there are differences in outcome between the two active treatments. To increase the generalizability of the investigators' results, the investigators want to perform the study as a multi-centre study.
- Conditions
- Shoulder Pain, Tendonitis, Calcinosis, Shoulder Impingement Syndrome
- Being tested
- Barbotage, Corticosteroid injection, Lidocain injection (sham)
- Keywords
- shoulder pain, rotator cuff, calcific tendonitis, barbotage
- Medical subject headings
- Shoulder Pain, Tendinopathy, Calcinosis, Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BarbotageProcedure or surgery
Also called 20 mg Triamcinolon/, 9 ml Lidocain 1%
A 18-gauge needle connected to a 5 ml syringe with 4 ml of saline solution will be used to puncture the calcification with freehand technique and under constant sonographic monitoring. With the tip of the needle placed in the center of the deposit, the calcification will be flushed. Finally, a new 21-gauge needle will be introduced into the subacromial-subdeltoid bursa and 9 ml of 1% Lidocain hydrochlorid and 1 ml (20 mg) of Triamcinolon will be injected into the subacromial-subdeltoid bursa. All patients will be instructed by a physioteherapist in home exercises.
Corticosteroid injectionProcedure or surgery
Also called 9 ml Lidocain 1%, 20 mg Triamcinolon/
The tip of the 18-gauge needle will be placed in the soft parts outside of the rotator cuff and movements mimicking the lavage procedure will be performed. A lavage procedure usually takes 5 minutes and the same period of time will have to be used for the mimicking maneuver. Finally, a new 21-gauge needle will be introduced into the subacromial-subdeltoid bursa and 9 ml of 1% Lidocain hydrochlorid and 1 ml (20 mg) of Triamcinolon will be injected into the subacromial-subdeltoid bursa. All patients will be instructed by a physioteherapist in home exercises.
Lidocain injection (sham)Procedure or surgery
Also called 9 ml Lidocain 1%
The tip of the 18-gauge needle will be placed in the soft parts outside of the rotator cuff and movements mimicking the lavage procedure will be performed. A lavage procedure usually takes 5 minutes and the same period of time will have to be used for the mimicking maneuver. Finally, a new 21-gauge needle will be introduced into the subacromial-subdeltoid bursa and 10 ml of 1% Lidocain hydrochlorid will be injected into the subacromial-subdeltoid bursa. All patients will be instructed by a physioteherapist in home exercises.
| Study group | Role | What they receive |
|---|---|---|
| Barbotage | Experimental | Ultrasound guided needling, lavage and steroid/lidocain injection (20 mg Triamcinolon/9 ml Lidocain 1%) Ultrasound guided lidocain injection (10 ml Lidocain 1%, sham group) and home exercises Receives: Procedure: Barbotage |
| Corticosteroid injection | Active comparator | Ultrasound guided steroid/lidocain injection (20 mg Triamcinolon/9 ml Lidocain 1%) and home exercises Receives: Procedure: Corticosteroid injection |
| Lidocain injection (sham) | Sham comparator | Ultrasound guided lidocain injection (10 ml Lidocain 1%, sham group) and home exercises Receives: Procedure: Lidocain injection (sham) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxford Shoulder Score
Shoulder pain and disability
Measured: 4 months
Secondary outcomes (5)
Oxford Shoulder Score
Shoulder pain and disability
Measured: after 2 and 6 weeks, and 8, 12 and 24 months
QuickDASH Disability of shoulder, arm and hand
Shoulder pain and disability
Measured: after 2 and 6 weeks, and 4, 8, 12 and 24 months
EQ 5D-5L
Health related quality of life
Measured: 4, 8, 12 and 24 months
Cross-over of patients
number of patients crossing over to other group or other treatment
Measured: 4, 8, 12 and 24 months
Adverse-events
Patient reported adverse events
Measured: 2 and 6 weeks, and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2022
- Study completionApr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vestre Viken Hospital Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Fonna, Oslo University Hospital, Sykehuset i Vestfold HF, Haraldsplass Deaconess Hospital, University Hospital, Linkoeping
- Responsible party
- Principal investigator, Stefan Moosmayer, Vestre Viken Hospital Trust
- Investigators
- Stefan Moosmayer, MD, PhD, Principal investigator, MHH Martine Hansens Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02419040
- Sponsor's protocol ID
- KALK-001
- Status last verified
- Oct 2023
- First submitted
- 10 Apr 2015
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Moosmayer S, Ekeberg OM, Hallgren HB, Heier I, Kvalheim S, Blomquist J, Pripp AH, Juel NG, Kjellevold SH, Brox JI; KALK study group. KALK study: ultrasound guided needling and lavage (barbotage) with steroid injection versus sham barbotage with and without steroid injection - protocol for a randomized, double-blinded, controlled, multicenter study. BMC Musculoskelet Disord. 2017 Apr 4;18(1):138. doi: 10.1186/s12891-017-1501-9.
PubMed 28376756Robinson DM, McInnis KC, Rhim HC, Tsitsilianos N. Lavage treatments for calcific rotator cuff tendinopathy. BMJ. 2023 Oct 11;383:2248. doi: 10.1136/bmj.p2248. No abstract available.
PubMed 37821118Moosmayer S, Ekeberg OM, Hallgren HB, Heier I, Kvalheim S, Juel NG, Blomquist J, Pripp AH, Brox JI. Ultrasound guided lavage with corticosteroid injection versus sham lavage with and without corticosteroid injection for calcific tendinopathy of shoulder: randomised double blinded multi-arm study. BMJ. 2023 Oct 11;383:e076447. doi: 10.1136/bmj-2023-076447.
PubMed 37821122
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Calcific Tendinitis of the Rotator Cuff - a Multi-centre, Randomized and Sham Controlled Trial (KALK Study)
- ClinicalTrials.gov ID
- NCT02419040
- Acronym / sponsor ID
- KALK-001
- Conditions
- Shoulder Pain, Tendonitis, Calcinosis, Shoulder Impingement Syndrome
- Keywords
- shoulder pain, rotator cuff, calcific tendonitis, barbotage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Vestre Viken Hospital TrustUniversity, hospital or other
- Collaborators
- Helse Fonna, Oslo University Hospital, Sykehuset i Vestfold HF, Haraldsplass Deaconess Hospital, University Hospital, Linkoeping
- Study start
- Apr 2015 (actual)
- Primary completion
- Apr 2022 (actual)
- Study completion
- Apr 2022 (actual)
- First posted
- 17 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether the combination of removal of the calcification in calcific tendinitis of the shoulder (supraspinatus and/or infraspinatus tendon) by aspiration with a needle and syringe (barbotage) and a corticosteroid injection is more effective than corticosteroid or sham injection alone.
Detailed description
Barbotage is a sonographically guided percutaneous needle aspiration and lavage of the calcium deposit in calcific tendinitis of the shoulder. Persisting pain in cacific tendinitis is considered to be a consequence of increased tendon volume or changed tendon texture in the area of the calcification which leads to secondary impingement and inflammation. Consequently, removal of the deposit should be a causal treatment measure.
Scientific evidence for the efficacy of the barbotage procedure in patients with persistent symptoms from calcific tendinitis is still limited. The cyclic often self-limiting course of the disease, and an anticipated placebo effect, questions about the method's efficacy can only be answered by high-quality randomized studies. In this trial the investigators want to randomize a cohort of patients to (1) Ultrasound guided needling, lavage and subacromial steroid injection, (2) Ultrasound guided subacromial steroid injection or (3) Ultrasound guided lidocain injection (sham). The investigators want to follow the patients over two years with repeated testing with a set of validated outcome measures together with radiologic re-examinations. The investigators want to find out whether the active treatments (1, 2) are more effective than the sham treatment and whether there are differences in outcome between the two active treatments. To increase the generalizability of the investigators' results, the investigators want to perform the study as a multi-centre study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Barbotage | Experimental | Procedure: BarbotageUltrasound guided needling, lavage and steroid/lidocain injection (20 mg Triamcinolon/9 ml Lidocain 1%) Ultrasound guided lidocain injection (10 ml Lidocain 1%, sham group) and home exercises |
| Corticosteroid injection | Active comparator | Procedure: Corticosteroid injectionUltrasound guided steroid/lidocain injection (20 mg Triamcinolon/9 ml Lidocain 1%) and home exercises |
| Lidocain injection (sham) | Sham comparator | Procedure: Lidocain injection (sham)Ultrasound guided lidocain injection (10 ml Lidocain 1%, sham group) and home exercises |
Who may qualify
- Ages
- 30 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 30 years or older
- 3 months or more of shoulder pain
- Moderate to strong pain localized on the top and/or lateral side of the shoulder, exaggerated by activities above shoulder level
- Painful arc
- Positive Hawkin's test and/or Neer's sign for impingement
Key exclusion criteria (12 listed)
- Clinical and radiological signs of a recent spontaneous release of the deposit such as a sudden change in size or density of the deposit on ultrasound together with an acute onset of extreme shoulder pain
- Clinical signs of shoulder instability, glenohumeral arthritis, AC pathology, inflammatory arthropathy, fibromyalgia, frozen shoulder or cervical radiculopathy
- Sonographic signs for a rotator cuff tear (full thickness or partial thickness) and of a tear or a dislocation of the long head of the biceps tendon
- A history of surgical treatment of the relevant shoulder
- A subacromial injection with a corticosteroid during the last 3 months before inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BarbotageAlso: 20 mg Triamcinolon/, 9 ml Lidocain 1%A 18-gauge needle connected to a 5 ml syringe with 4 ml of saline solution will be used to puncture the calcification with freehand technique and under constant sonographic monitoring. With the tip of the needle placed in the center of the deposit, the calcification will be flushed. Finally, a new 21-gauge needle will be introduced into the subacromial-subdeltoid bursa and 9 ml of 1% Lidocain hydrochlorid and 1 ml (20 mg) of Triamcinolon will be injected into the subacromial-subdeltoid bursa. All patients will be instructed by a physioteherapist in home exercises. | Procedure or surgery | Barbotage |
| Corticosteroid injectionAlso: 9 ml Lidocain 1%, 20 mg Triamcinolon/The tip of the 18-gauge needle will be placed in the soft parts outside of the rotator cuff and movements mimicking the lavage procedure will be performed. A lavage procedure usually takes 5 minutes and the same period of time will have to be used for the mimicking maneuver. Finally, a new 21-gauge needle will be introduced into the subacromial-subdeltoid bursa and 9 ml of 1% Lidocain hydrochlorid and 1 ml (20 mg) of Triamcinolon will be injected into the subacromial-subdeltoid bursa. All patients will be instructed by a physioteherapist in home exercises. | Procedure or surgery | Corticosteroid injection |
| Lidocain injection (sham)Also: 9 ml Lidocain 1%The tip of the 18-gauge needle will be placed in the soft parts outside of the rotator cuff and movements mimicking the lavage procedure will be performed. A lavage procedure usually takes 5 minutes and the same period of time will have to be used for the mimicking maneuver. Finally, a new 21-gauge needle will be introduced into the subacromial-subdeltoid bursa and 10 ml of 1% Lidocain hydrochlorid will be injected into the subacromial-subdeltoid bursa. All patients will be instructed by a physioteherapist in home exercises. | Procedure or surgery | Lidocain injection (sham) |
Primary outcome
Oxford Shoulder Score
Time frame: 4 months
Shoulder pain and disability
5 secondary outcomes
Oxford Shoulder Score
Time frame: after 2 and 6 weeks, and 8, 12 and 24 months
QuickDASH Disability of shoulder, arm and hand
Time frame: after 2 and 6 weeks, and 4, 8, 12 and 24 months
EQ 5D-5L
Time frame: 4, 8, 12 and 24 months
Cross-over of patients
Time frame: 4, 8, 12 and 24 months
Adverse-events
Time frame: 2 and 6 weeks, and 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Background: PubMed 28376756Moosmayer S, Ekeberg OM, Hallgren HB, Heier I, Kvalheim S, Blomquist J, Pripp AH, Juel NG, Kjellevold SH, Brox JI; KALK study group. KALK study: ultrasound guided needling and lavage (barbotage) with steroid injection versus sham barbotage with and without steroid injection - protocol for a randomized, double-blinded, controlled, multicenter study. BMC Musculoskelet Disord. 2017 Apr 4;18(1):138. doi: 10.1186/s12891-017-1501-9.
- Background: PubMed 37821118Robinson DM, McInnis KC, Rhim HC, Tsitsilianos N. Lavage treatments for calcific rotator cuff tendinopathy. BMJ. 2023 Oct 11;383:2248. doi: 10.1136/bmj.p2248. No abstract available.
- Results publication: PubMed 37821122Moosmayer S, Ekeberg OM, Hallgren HB, Heier I, Kvalheim S, Juel NG, Blomquist J, Pripp AH, Brox JI. Ultrasound guided lavage with corticosteroid injection versus sham lavage with and without corticosteroid injection for calcific tendinopathy of shoulder: randomised double blinded multi-arm study. BMJ. 2023 Oct 11;383:e076447. doi: 10.1136/bmj-2023-076447.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Moosmayer, MD, PhD principal investigator
MHH Martine Hansens Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Barbotage and Corticosteroid injection in people with Shoulder Pain and Tendonitis, run by Vestre Viken Hospital Trust at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxford Shoulder Score (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02419040, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.